Raleigh, NC-based BioDelivery Sciences International ($BDSI) is announcing positive preliminary results from its Phase I study of a high dose formulation of buprenorphine combined with naloxone (abuse deterrent agent) to treat opioid dependence. BDSI's secret sauce is its BioErodible MucoAdhesive drug delivery technology, which is a small, polymer film that is designed to degrade in the body in a non-toxic manner and is placed on the inner lining of the cheek. With opioid dependence reaching, by some accounts, epidemic proportions, there is a potentially big market for this drug and delivery method.
"We are pleased with the results of this study as they are consistent with our expectations and allow us to now optimize our BEMA Buprenorphine/Naloxone formulation prior to conducting the pivotal bioequivalence study," BDSI's Andrew Finn said in a statement. "We expect to initiate the pivotal bioequivalence trial in December of this year with results expected during the first quarter of 2012. If the results from this pivotal study are positive, we could be in a position to submit a New Drug Application (NDA) for BEMA Buprenorphine/Naloxone in the second half of 2012."
The formulation is the first to include two drugs, according to the company: high dose buprenorphine, which takes care of the craving and withdrawal effects from an opioid, and an opioid antagonist, naloxone, to deter abuse.
- read BDSI's release